How to Use Confluence Pages as Templates

Summary SoftComply has released a new Confluence Server macro within the SoftComply eQMS app that allows the user to use any Confluence page as a template, copying it automatically into the existing space at a click of a button. Features include the addition of prefixes, suffixes, timestamp and more. This bypasses the use of Confluence […]

How Cibiltech became FDA 21 CFR 11 Compliant on Atlassian Confluence

Customer Story on the MediCompli Solution at Cibiltech NOTE: Cibiltech has now successfully migrated from Atlassian Server to Atlassian Cloud and have implemented the Cloud eQMS Solution as their Quality Management Solution. Cibiltech Cibiltech is a French medical device company developing an AI based personalized medicine solution for better patient care. Their most recent solution […]

How SoftComply eQMS helped speed up the CE-marking of munevo DRIVE – a Case Study

“If you are developing medical device software and need to go through the certification process, look what SoftComply has to offer!”, says Claudiu, the co-founder and CEO of Munevo. Munevo is the company behind munevo DRIVE – the first wheelchair control system that uses smart glasses enabling people to become more independent and safely drive […]

How to Secure your Documents in Confluence?

This short post will provide you insight into taking control over your document management in Confluence Server. This post is not going to touch regular security policies like VPN, firewalls, security policies and ohter things that are outside of the Confluence Server. In other words, all the really technical things are left out and we […]

What is Software Tool Validation?

Modern medical device regulations are putting more and more emphasis on the management of software tools. These tools are software packages that are not part of the medical devices themselves, but support the device during its lifecycle. Nowadays companies use dozens of applications, ranging from accounting tools to email clients to software compilers. Of course […]

The Importance of IEC 62304 Compliance Part 2

Following up on our first blog post on how to become a trusted software supplier to established medical device manufacturers with the help of IEC 62304, we will now shed some light on specific clauses and requirements of that standard. IEC 62304:2006/Amd 1:2015, 4.3 – Software Safety Classification The 2015 amendment provides more clarity on […]

The Importance of IEC 62304 Compliance

IEC 62304 outlines the guiding principles for the development of medical software. It is the gold standards for medical device companies, but its importance goes beyond legal manufacturers and established medical software suppliers. In the vast majority of cases, software embedded in a device (or a device itself) use abundant OTS (Off The Shelf) code, […]

New Medical Devices Regulation & Risk Management

The revised Medical Devices Regulation (MDR) will change the regulatory environment of medical devices in Europe to a more stringent one. Compared to the MDD, the MDR promotes a life-cycle approach similar to what the US FDA and many international standards advocate. MDR highlights the importance of medical device risk management. Although risk management has […]